1. PROTECT Progesterone for Traumatic brain injury

2. What was the PROTECT study? Multicenter Moderate to severe trauma to the brain Patients enrolled within 4 hours of injury Patients initially started in the study without consent Patients given progesterone or placebo for 4 days Patients followed for 6 months The goal was to see if progesterone treatment improved the mental function of patients who suffered a traumatic brain injury.

3. Who was in the study? The median age was 35 Most were from car accidents 73.7% of patients were male nationwide 15.2% of patients were black nationwide 14.2% of patients were Hispanic nationwide In Houston, 79% of our patients were male, 13.6% were black and 40.9% were Hispanic.

4. Results 882 patients enrolled nationwide Study stopped early because no benefit was seen from giving the progesterone. Good mental outcomes were the same in each group. Death rates were similar in each group. The amount of disability patients were left with was similar in both groups.

5. Side effects More patients who got progesterone had small clots or inflammation in their veins. 17.2% of patients who got progesterone had problems with their veins versus 5.7% who got placebo. Rates of heart attack, blood clots in the lung, stroke, large blood clots, pneumonia, blood infections, brain infections or liver injury were the same in both groups.

6. Conclusion Progesterone in traumatic brain injury was safe to give, but did not improve the outcomes of patients.